This study is a Phase 1/2, first-in-human, open-label, dose-escalation and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetics, preliminary antitumor activity and immunogenicity of 9MW2821 administered by intravenous (IV) infusion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
208
All subjects will receive a single intravenous (IV) infusion of 9MW2821 once weekly for the first 3 weeks of every 4 week cycle (i.e., on Days 1, 8 and 15).
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGIncidence of adverse events
Time frame: Up to 28 days post last drug administration
Objective Response Rate (Phase 2)
Defined as the percentage of subjects who experience a best response of either CR or PR. CR and PR must be confirmed ≥ 28 days later.
Time frame: Up to 24 months
Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)
Maximum observed concentration (Cmax)
Time frame: 24 months
Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)
Area under the concentration-time curve (AUC)
Time frame: 24 months
Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)
Half-life (t1/2)
Time frame: 24 months
Pharmacokinetic parameter for total antibody (TAb), antibody drug conjugate (ADC), and Monomethyl Auristatin E (MMAE)
Clearance (CL)
Time frame: 24 months
Disease Control Rate
Defined as the percentage of subjects who experience a best response of CR, PR or stable disease (SD)
Time frame: Up to 24 months
Duration of Response
Time from the date of the first complete response (CR) or partial response (PR) to the earliest date of disease progression or death from any cause. DOR is only defined for subjects who have best overall response of CR or PR.
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Time frame: Up to 24 months
Time to Response
Time from the date of first infusion to the date of confirmed CR or PR
Time frame: Up to 24 months
Progression Free Survival
Time from the date of first infusion to the earliest date of documented disease progression per radiological evidence or death from any cause
Time frame: Up to 24 months
Overall Survival
Time from the date of first infusion until the date of death from any cause.
Time frame: Up to 24 months
Incidence of Anti-Drug Antibody (ADA)
Time frame: Up to 24 months